On September 2, 2020, the European Commission (EC) published the 15th amendment to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The EC had published and submitted a draft version of the amendment to the World Trade Organization (WTO) in March 2020 with an originally expected enforcement date in June 2020 (FPF reported).
The amendment follows through with changes described earlier, including the addition of three substances: (i) montmorillonite clay modified with hexadecyltrimethylammonium bromide, (ii) phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester (CAS 1227937-46-3), and (iii) titanium dioxide surface-treated with fluoride-modified alumina, including the nano form. Other changes include decreasing the non-detect limit for specific migration of (i) 1,3-phenylenediamine (CAS 108-45-2) from 0.01 mg/kg to 0.002 mg/kg food or food simulant and of (ii) primary aromatic amines from 0.01 mg/kg to 0.002 mg/kg food or food simulant. Specific migration limits for 24 elements were also updated or newly defined, and text was introduced allowing for migration testing to be done using entire appliances or pieces of equipment instead of verifying compliance of each individual part.
The amendment specifies a transition period allowing any plastic materials and articles that complied with the regulation before this amendment and “were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until the exhaustion of stocks.” This amended regulation will enter into force twenty days after publication in the EU’s official journal, which is on September 23, 2020.
EC (September 2, 2020). “Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.”
SGS (September 8, 2020). “EU Revises Food Contact Plastics Regulation.”
Chemical Watch (September 8, 2020). “Tougher EU plastic FCM chemical restrictions published.”
Keller and Heckmann LLP (September 9, 2020). “15th Amendment to the EU Plastics Regulation Published.”